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CandyCollect Strep Throat Testing
This study will enroll children ages 5-17 who test positive for Group A Streptococcus (GAS) at a single clinic visit lasting approximately 30-60 minutes. The primary aim of this study is to assess the accuracy and feasibility of the CandyCollect platform to capture and detect GAS. The investigators hypothesize that the CandyCollect platform is non-inferior to gold-standard rapid antigen detection testing for GAS.
Conditions:
🦠 Group A Streptococcal Infection
🗓️ Study Start (Actual) 10 January 2023
🗓️ Primary Completion (Estimated) May 2025
✅ Study Completion (Estimated) May 2025
👥 Enrollment (Estimated) 140
🔬 Study Type INTERVENTIONAL
📊 Phase NA
Locations:
📍 Madison, Wisconsin, United States

📋 Eligibility Criteria

Description

    Inclusion Criteria:

    • * Child age 5-17 years old
    • * Diagnosis of acute pharyngitis caused by GAS
    • * A positive RADT swab in clinic
    • * Able to assent and complete surveys in English

    Exclusion Criteria:

    • * Unable to suck on a swab or CandyCollect
    • * Previous participation in this study
    • * Self-reported sensitivity to sugar-free products
    • Inclusion for Caregiver Participants:
    • * Parent or legal guardian able to provide consent for child participant
    • * Physically present at the clinic with the child
    • * Able consent and complete surveys in English
    • Exclusion for Caregiver Participants:
    • * Does not meet inclusion criteria
Ages Eligible for Study: 5 Years to 17 Years (CHILD)
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: No

🗓️ Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

  • First Submitted 14 December 2021
  • First Submitted that Met QC Criteria 14 December 2021
  • First Posted 3 January 2022

Study Record Updates

  • Last Update Submitted that Met QC Criteria 29 March 2024
  • Last Update Posted 1 April 2024
  • Last Verified March 2024
I'm interested ...!!